Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767620
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2021-02-09
Brief Title:
Clinical Trial of Ruxian Zengsheng No 1 Decoction
Sponsor:
Jiuda Zhao
Organization:
Affiliated Hospital of Qinghai University
Study Overview
Official Title:
A Prospective Open Randomized Controlled Phase Ⅱ Clinical Study of Ruxian Zengsheng No 1 Decoction in Treating Liver-stagnation and Qi-stagnation Hyperplasia of Breast
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective open randomized controlled phase II clinical study is planned to clarify the efficacy and related adverse reactions of Mammary Glandular Hyperplasia No 1 Decoction in the treatment of liver-qi stagnation type breast hyperplasia relieve the pain of patients with breast hyperplasia and improve the quality of life of patients
Detailed Description:
1 This study is a prospective open randomized controlled Phase II clinical study Strictly follow the design requirements of the clinical research randomly enroll patients control each link of the study with high quality and obtain objective research results to improve the evidence-based medicine evidence of the breast hyperplasia treatment of liver-stagnation and qi stagnation type breast hyperplasia with Rugongshengsheng No1 prescription
2 Recruiting 137 patients with liver-stagnation and qi stagnation type breast hyperplasia through the Breast Center Clinic of the Affiliated Hospital of Qinghai University see the inclusion criteria for details see the research plan for the specific calculation method and randomly divided into 91 cases according to the 21 random number method Group 46 cases of control group The research group was treated with No1 Rugdenzengsheng prescription for a total of 1 course of treatment each course of 14 days avoiding the menstrual period The control group was given observation treatment and follow-up in outpatient clinic All patients will be followed up by telephone or outpatient by a dedicated person and the results of the follow-up will be recorded objectively
3 Specific treatment plan The study group was treated with Mammary gland Hyperplasia No 1 orally a total of 1 course of treatment each course of 14 days avoiding the menstrual period The specific composition of Mammary Gland Hyperplasia No 1 Recipe Angelica 10g Radix Paeoniae Alba 10g Atractylodes Macrocephala 10g Ginger 3g Peppermint 6g Vinegar Green Peel 6g Lychee Seed 12g Tangerine Seed 10g Corydalis 10g Fritillaria 6g Trichosanthis 10g Kombu 20g Mustard seeds 10g Moutan bark 6g Poria 10g Beibuihu 6g Method of administration 14 doses in total taken twice a day The medicine is formulated in the herbal medicine room of the Affiliated Hospital of Qinghai University with strict quality control
4 All patients will be followed up by telephone or on-site within one week after treatment The evaluation criteria are detailed in the attached table The curative effect evaluation standard of hyperplasia of mammary glands is mainly through the scoring method The analgesic curative effect standard NRS score on the most painful day clinical recovery the pain disappears completely marked effect the pain is significantly reduced only occasional pain or only slight tenderness effective Pain is reduced or tenderness is reduced Ineffective Pain remains unchanged or worsened In addition collect clinical pathological data of patients such as age gender reproductive history menstrual history family history breastfeeding history etc
5 Secondary efficacy indicators safety evaluation safety endpoints include the incidence of adverse events and adverse reactions liver function renal function and urine routine laboratory examinations before and after treatment
6 Apply for ethical review by the ethics committee of the Affiliated Hospital of Qinghai University and conduct research in strict accordance with the ethical requirements of the ethics committee of the Affiliated Hospital of Qinghai University
2 Recruiting 137 patients with liver-stagnation and qi stagnation type breast hyperplasia through the Breast Center Clinic of the Affiliated Hospital of Qinghai University see the inclusion criteria for details see the research plan for the specific calculation method and randomly divided into 91 cases according to the 21 random number method Group 46 cases of control group The research group was treated with No1 Rugdenzengsheng prescription for a total of 1 course of treatment each course of 14 days avoiding the menstrual period The control group was given observation treatment and follow-up in outpatient clinic All patients will be followed up by telephone or outpatient by a dedicated person and the results of the follow-up will be recorded objectively
3 Specific treatment plan The study group was treated with Mammary gland Hyperplasia No 1 orally a total of 1 course of treatment each course of 14 days avoiding the menstrual period The specific composition of Mammary Gland Hyperplasia No 1 Recipe Angelica 10g Radix Paeoniae Alba 10g Atractylodes Macrocephala 10g Ginger 3g Peppermint 6g Vinegar Green Peel 6g Lychee Seed 12g Tangerine Seed 10g Corydalis 10g Fritillaria 6g Trichosanthis 10g Kombu 20g Mustard seeds 10g Moutan bark 6g Poria 10g Beibuihu 6g Method of administration 14 doses in total taken twice a day The medicine is formulated in the herbal medicine room of the Affiliated Hospital of Qinghai University with strict quality control
4 All patients will be followed up by telephone or on-site within one week after treatment The evaluation criteria are detailed in the attached table The curative effect evaluation standard of hyperplasia of mammary glands is mainly through the scoring method The analgesic curative effect standard NRS score on the most painful day clinical recovery the pain disappears completely marked effect the pain is significantly reduced only occasional pain or only slight tenderness effective Pain is reduced or tenderness is reduced Ineffective Pain remains unchanged or worsened In addition collect clinical pathological data of patients such as age gender reproductive history menstrual history family history breastfeeding history etc
5 Secondary efficacy indicators safety evaluation safety endpoints include the incidence of adverse events and adverse reactions liver function renal function and urine routine laboratory examinations before and after treatment
6 Apply for ethical review by the ethics committee of the Affiliated Hospital of Qinghai University and conduct research in strict accordance with the ethical requirements of the ethics committee of the Affiliated Hospital of Qinghai University
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None